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Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Report symptoms via web or phone-based system
Sponsored by
BrightOutcome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Patient Reported Outcomes (PRO), Web-based, Phone-based, Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female, breast oncology patient
  • Breast cancer diagnosis
  • Expected chemotherapy regimen of at least 3-4 months
  • Sufficient cognitive ability and psychological stability in the opinion of treating physician
  • Fluent in spoken and written English
  • 18 years of age or older
  • Outpatient
  • Life expectancy > 6 months as estimated by treating physician
  • Informed of the investigational nature of this study and provided informed consent.
  • Has access to either a phone or the internet

Exclusion Criteria:

  • Is not female, nor a breast oncology patient
  • Does not have breast cancer diagnosis
  • Expected chemotherapy regimen is less than 3-4 months
  • Does not have sufficient cognitive ability and psychological stability in the opinion of treating physician
  • Is not fluent in spoken and written English
  • Is younger than 18 years of age
  • Inpatient
  • Life expectancy < 6 months as estimated by treating physician
  • Is not informed of the investigational nature of this study and does not provide informed consent.
  • Does not have access to either a phone or internet.

Sites / Locations

  • Arizona Cancer Center
  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

The participant used the web and/or phone-based PRO reporting symptoms to enter symptoms twice a week at minimum.

The participants on this arm do not record their symptoms. They report symptoms as they would under usual care.

Outcomes

Primary Outcome Measures

Usability and effectiveness of the prototype
Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication

Secondary Outcome Measures

Full Information

First Posted
April 20, 2010
Last Updated
February 2, 2012
Sponsor
BrightOutcome
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01108315
Brief Title
Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
Official Title
Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
BrightOutcome
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver. When the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or PROs. The questionnaires used to collect this information are called PRO instruments. The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined. PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Patient Reported Outcomes (PRO), Web-based, Phone-based, Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The participant used the web and/or phone-based PRO reporting symptoms to enter symptoms twice a week at minimum.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The participants on this arm do not record their symptoms. They report symptoms as they would under usual care.
Intervention Type
Other
Intervention Name(s)
Report symptoms via web or phone-based system
Intervention Description
The participant reports their symptoms at least twice a week via the phone or web-based prototype system.
Primary Outcome Measure Information:
Title
Usability and effectiveness of the prototype
Description
Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female, breast oncology patient Breast cancer diagnosis Expected chemotherapy regimen of at least 3-4 months Sufficient cognitive ability and psychological stability in the opinion of treating physician Fluent in spoken and written English 18 years of age or older Outpatient Life expectancy > 6 months as estimated by treating physician Informed of the investigational nature of this study and provided informed consent. Has access to either a phone or the internet Exclusion Criteria: Is not female, nor a breast oncology patient Does not have breast cancer diagnosis Expected chemotherapy regimen is less than 3-4 months Does not have sufficient cognitive ability and psychological stability in the opinion of treating physician Is not fluent in spoken and written English Is younger than 18 years of age Inpatient Life expectancy < 6 months as estimated by treating physician Is not informed of the investigational nature of this study and does not provide informed consent. Does not have access to either a phone or internet.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DerShung Yang, PhD
Organizational Affiliation
BrightOutcome
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
VK Gadi, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Maria Lopez, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

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